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Poly Diagnostics Influenza A, Influenza B, SARS-CoV-2, RNase P Real-Time PCR kit

by Poly Diagnostics 4 variants

Ref PD3L48

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5430004263PD3VE Basic UDI-DI 05430005087778UDI-DIDate21 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Poly Diagnostics Influenza A, Influenza B, SARS-CoV-2, RNase P Real-Time PCR kit
Model / Reference
PD3L48
Primary DI / UDI-DI
05430005087778
Basic UDI-DI
5430004263PD3VE
EMDN Code
W0105070503 Respiratory tract infections - multiplex na reagents
Device Class
Class B
EU market of registration
Luxembourg

Manufacturer details

EUDAMED SRN
LU-MF-000042647

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See all devices from Poly Diagnostics →

Properties

  • Reagent
  • Professional Testing
  • New Device

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No